Contribution of a Hand-held Gamma Camera (TreCam) to the SNOLL(Occult Breast Lesion Localization Plus Sentinel Node Biopsy) Procedure in Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Rate of further surgery for non in sano or inadequate (less than 3 mm security margins) lumpectomy piece's margins.
Study Overview
Brief Summary
In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. The main problem of the surgical management of these lesions is the quality of preoperative identification which determines the quality of surgery and oncological and cosmetic outcomes. For this type of lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed. This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The investigators want to evaluate the potential benefits of using a hand held camera called TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside and in the operating theater.
Detailed Description
Hypothesis:
The use of intraoperative TReCam improves the surgical procedure by providing relevant information during surgery to reduce the rate of further surgery for inappropriate margins.
Main Objective:
Evaluation of the contribution of TreCam in SNOLL procedure.
Main endpoint:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients older than 18 years
- •Patients undergoing SNOLL procedure for breast non palpable invasive cancer (ultrasound image target) confirmed by biopsy before surgery
- •Clinical T0N0 stage
- •Before the SNOLL procedure, patients will be informed on all this procedure
- •A free and informed consent must be obtained
Exclusion Criteria
- •Multifocal breast cancer, diffuse microcalcifications
- •Non-palpable breast cancer without ultrasound target
- •Isolated in situ cancer or invasive cancer associated with extended in situ carcinoma
- •Patients who underwent neoadjuvant chemotherapy
- •Palpable axillary nodes on clinical examination or with a suspicious or positive cytology
- •Pregnant patient
- •History of axillary surgery or mammoplasty
- •Allergy to any component of the tracking technique
Arms & Interventions
Group 1
Patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam.
Group 2
Patients with a resection of the lesions according to the procedure SNOLL with the use of TReCam.
Intervention: TRECAM (Device)
Outcomes
Primary Outcomes
Rate of further surgery for non in sano or inadequate (less than 3 mm security margins) lumpectomy piece's margins.
Time Frame: Between 2 and 3 weeks
Secondary Outcomes
- Status of resection margins(one day)
- Size, volume and weight of the lumpectomy.(between 2 and 3 weeks)
- Duration of utilization of TreCam at at the end of lumpectomy for acquisition of images of the tumor's bed after removal of the radioactive target and for acquisition of image of the lumpectomy's specimen.(One day)
- Difficulties in data acquisition Using a scale of 4 items : VERY EASY, EASY, DIFFICULT, IMPOSSIBLE(one day)
- Cosmetics results: 4 point Score(between 2 and 3 weeks)
- Morbidity(between 2 and 3 weeks)
- Volume of resection / tumor volume(between 2 and 3 weeks)
- Duration of utilization of TreCam at at the end of the SLN procedure for verifying the absence of radioactivity.(One Day)
- Duration of utilization of TreCam at The day before surgery and before induction of anesthesia for the location of the breast injection site and SLN.(2 days)
- Duration of utilization of TreCam at each step of the procedure during the breast exploration before lumpectomy.(One day before the surgery)
- Comparison between imaging data provided in preoperative time by TreCam and by standard LS: image's quality, location of the injection's site, location and number of SLN.(One day)